MSB 6.07% $1.01 mesoblast limited

Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-21

  1. 6,445 Posts.
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    FDA will never give you a straight YES during initial discussions. That's what the approval process is for. It's a strong indication of what they think of the data at this time. And its not like they are dealing with it for the first rime. This is a very controversial issue, so for them to give the green light to submit with no clinical trial requirements, is as good as you'll get at this time in the process.
 
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